Unveiling the differences: infection disorders associated with tumor necrosis factor α inhibitors in pediatric patients-a pharmacovigilance study (2004-2023).
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UNLABELLED: The increasing use of tumor necrosis factor inhibitors (TNFi) in pediatric patients has raised concerns about their potential impact on the immune system and related adverse events. Infection-related adverse events (AEs) caused by TNFi have already raised widespread concerns in real-world settings. This study aims to comprehensively analyze and summarize the infection-related AEs associated with TNFi in pediatric patients. A retrospective pharmacovigilance study was conducted to identify cases of TNFi-related infections reported to the FDA Adverse Event Reporting System (FAERS) database between Q1 2004 and Q1 2023. TNFi reports were carefully reviewed to exclude confounding factors like other AEs, concomitant medications, and prescription indications. Proportionality analysis was conducted by comparing TNFi reports to the entire FAERS database to identify infection-related AEs significantly associated with TNFi use. Infection-related AEs accounted for 8.36% of all TNFi-related adverse event reports in the FAERS database. A total of 8050 cases of TNFi-associated infections were identified in the pediatric population, with 2.57% of reports resulting in fatalities. Infliximab and golimumab showed a stronger association with infection-related AEs compared to other TNFi. Notably, only adalimumab shows a lower risk of viral infections, while it exhibits an increased risk of bacterial and mycobacterial infections, similar to other TNFi. CONCLUSIONS: This study identified a significant association between TNFi use and infection-related AEs in pediatric patients, providing the foothold for further research. However, due to its retrospective nature, further investigations are warranted to confirm these findings and identify potential risk factors in a controlled, prospective study setting. WHAT IS KNOWN: • There is sufficient evidence to demonstrate the infection risk associated with TNFi in adult patients. • Pediatric patients, whose immune systems are still developing, are more vulnerable to certain infections. WHAT IS NEW: • There is a significant association between TNFi use and infection-related adverse events in pediatric patients, and different TNFi have distinct infection profiles.